|- candidate number||23382|
|- NTR Number||NTR5629|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-nov-2015|
|- Secondary IDs|| NL54611.091.15 METC|
|- Public Title||Multisensory stimulation in patients with hemispatial neglect.
|- Scientific Title||Feasibility of multisensory stimulation to improve visual detection in stroke patients with hemispatial neglect|
|- ACRONYM||multistory stimulation in hemispatial neglect patients|
|- hypothesis||Synchronous visuo-tactile signals will facilitate the patients’ intrinsic ability to voluntarily control attention towards the sensory stimuli in the neglected hemispace allowing them to be consciously processed. |
|- Healt Condition(s) or Problem(s) studied||Hemispatial neglect syndrome|
|- Inclusion criteria||•Men/women of 18
•Presence of hemispatial neglect following stroke.|
•Written informed consent after being fully informed about any possible discomfort they might experience during participation.
•Normal or corrected-to-normal visual acuity.
|- Exclusion criteria||•Severe visual impairments (Diabetic retinopathy, cataracts) .|
•Visual-field defects (e.g., Hemianopia).
•History of psychiatric disorders or substance abuse.
•Severe cognitive impairments (MMSE<18).
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jan-2016|
|- planned closingdate||1-jan-2018|
|- Target number of participants||20|
|- Interventions||we will compare the performance of patients in detecting sensory stimuli presented in the neglected hemispace under two different conditions that differ from each other by the properties of the sensory stimuli; 1) unisensory with only visual or only tactile stimulation, 2) multisensory with synchronous visuo-tactile stimulation.|
|- Primary outcome||The statistical design will focus on the comparison of number of sensory stimuli detected in the neglected hemispace when presented in a unisensory fashion and when presented in multisensory fashion.|
|- Secondary outcome||-|
|- Timepoints||There is one measurement session. |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Drs Ahmed H. Gardoh|
|- CONTACT for SCIENTIFIC QUERIES||Drs Ahmed H. Gardoh|
|- Sponsor/Initiator ||Radboud University Nijmegen|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||11-nov-2015 - 27-feb-2016|